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ASAHI Gladius MG14 300cm Pre-shape

by Asahi Intecc Co., Ltd.

Ref AP14R323P

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04547327123716 Basic UDI-DI 04547327123716UDI-DIDate22 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04547327123716 UDI-DI Date31 Aug 2018ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
ASAHI Gladius MG14 300cm Pre-shape EUDAMED
ASAHI Gladius Mongo14 GUDID
Generic Name
Cardiac/peripheral vascular guidewire, single-use
Device Name
ASAHI PTCA Guide Wire ASAHI Gladius
Model / Reference
AP14R323P
Primary DI / UDI-DI
04547327123716
Basic UDI-DI
B-04547327123716
FDA Product Code
DQX
EMDN Code
C04030201 Interventional coronary and peripheral vascular guide wires, hydrophilic
GMDN Term
Cardiac/peripheral vascular guidewire, single-use
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
870.1330
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 0.014 Inch
Length — 300 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Manufacturer details

EUDAMED SRN
JP-MF-000010199
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Asahi Intecc Co., Ltd.

See all devices from Asahi Intecc Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No